1.5MM HEX, CMP FT
Report
- Report Number
- 1220246-2021-03895
- Event Type
- Malfunction
- Date Received
- November 8, 2021
- Date of Event
- October 18, 2021
- Report Date
- November 23, 2021
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867127159
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- 501
Narratives
COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8737-37, BATCH 1392013 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE DISTAL TIP OF THE RETURNED DRIVER HAD BROKEN, WITH NO FRAGMENTS RETURNED FOR ANALYSIS. DUE TO THE LOCATION OF THE BREAKAGE SITE, THE DIMENSIONS OF THE HEX FEATURE COULD NOT BE ACCURATELY ASSESSED. HOWEVER, DIMENSIONAL ANALYSIS WAS CONDUCTED ON THE DISTAL SHAFT OD PROXIMAL TO THE BREAKAGE SITE, AND IT WAS DETERMINED THAT THE RETURNED DEVICE MET DESIGN SPECIFICATIONS. THE CAUSE REMAINS UNDETERMINED.
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ON (B)(6) 2021 IT WAS REPORTED BY A DISTRIBUTOR REPRESENTATIVE VIA SEMS THAT MULTIPLE SCREW DRIVERS AR-8737-37 AND AR-8737-38 BROKE DURING AN IMPLANT REMOVAL SURGERY. FIRST AR-8737-38: 1.1MM GUIDEWIRE WAS INSERTED INSIDE THE 4MM COMP FT SCREW TO GUIDE THE SCREW DRIVER UNDER X-RAY, SCREW DRIVER INSERTED THEN FOLLOWED BY TWO MORE X-RAYS (AP&LATERAL) TO CONFIRM THE ALIGNMENT, FIRST SCREW DRIVER(AR-8737-38) BROKE AFTER 2-3 TURNS. THE INCISION HAD TO BE EXTENDED TO REMOVE 2 SMALL BROKEN PIECES BEFORE THE 2ND TRY. SECOND AR-8737-38: ANOTHER NEW 1.1MM GUIDEWIRE WAS INSERTED FOR GUIDING THE SCREW DRIVER WITH X-RAY CONFIRMATION SAME AS THE PREVIOUS ONE. THE SCREW DRIVER TIP WAS TWISTED WHILE TURNING. ABLE TO REMOVE THE SCREW WITH THE TWISTED SCREW DRIVER. 3RD SCREW DRIVER(AR-8737-37): 0.86MM GUIDEWIRE WAS INSERTED INSIDE THE 2.5MM COMP FT SCREW TO GUIDE THE SCREW DRIVER UNDER X-RAY, SCREW DRIVER INSERTED THEN FOLLOWED BY TWO MORE X-RAY(AP&LATERAL) TO CONFIRM THE ALIGNMENT, SCREW DRIVER TIP BROKE INSIDE SCREW AFTER 2-3 TURNS, BROKEN PIECE COULD NOT BE REMOVED. THE SCREW WAS VISIBLE AS AN ENHANCED SHADOW ON X-RAY.
ON (B)(6) 2021 IT WAS REPORTED BY A DISTRIBUTOR REPRESENTATIVE VIA SEMS THAT MULTIPLE SCREW DRIVERS AR-8737-37 AND AR-8737-38 BROKE DURING AN IMPLANT REMOVAL SURGERY. FIRST AR-8737-38: 1.1MM GUIDEWIRE WAS INSERTED INSIDE THE 4MM COMP FT SCREW TO GUIDE THE SCREW DRIVER UNDER X-RAY, SCREW DRIVER INSERTED THEN FOLLOWED BY TWO MORE X-RAYS (AP&LATERAL) TO CONFIRM THE ALIGNMENT, FIRST SCREW DRIVER(AR-8737-38) BROKE AFTER 2-3 TURNS. THE INCISION HAD TO BE EXTENDED TO REMOVE 2 SMALL BROKEN PIECES BEFORE THE 2ND TRY. SECOND AR-8737-38: ANOTHER NEW 1.1MM GUIDEWIRE WAS INSERTED FOR GUIDING THE SCREW DRIVER WITH X-RAY CONFIRMATION SAME AS THE PREVIOUS ONE. THE SCREW DRIVER TIP WAS TWISTED WHILE TURNING. ABLE TO REMOVE THE SCREW WITH THE TWISTED SCREW DRIVER. 3RD SCREW DRIVER(AR-8737-37): 0.86MM GUIDEWIRE WAS INSERTED INSIDE THE 2.5MM COMP FT SCREW TO GUIDE THE SCREW DRIVER UNDER X-RAY, SCREW DRIVER INSERTED THEN FOLLOWED BY TWO MORE X-RAY(AP&LATERAL) TO CONFIRM THE ALIGNMENT, SCREW DRIVER TIP BROKE INSIDE SCREW AFTER 2-3 TURNS, BROKEN PIECE COULD NOT BE REMOVED. THE SCREW WAS VISIBLE AS AN ENHANCED SHADOW ON X-RAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1663003 | 1.5MM HEX, CMP FT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHREX, INC. | 1.5MM HEX, CMP FT | UNK | 00888867127159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |